TEE Image Quality
Conditions
Brief summary
Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning of the case, and left there for intermittent suction as needed, or removed before TEE exam to prevent echoic artifacts. However, if left there, the effect of suction might be limited due to unreliable tip position of the OG tube. If removed, stomach will be distended again. We devised the OG tube attached TEE for practical suction and assessed its effect on image quality intraoperatively.
Detailed description
OGT attached TEE probe is used for cardiac and liver transplantation cases. Each case is assigned 3 investigators who are blinded to this study design, We do image quality assessment by two methods; firstly, we categorize image quality as numbers based on each investigator's impression (1: Very bad, 2: bad, 3: acceptable, 4: good, 5: very good) and compare the difference in number before and after suctioning. Secondly, we evaluate consistency intraclass correlation coefficient (ICC) for inter-observer variability using investigator A, B and C. We evaluate absolute-agreement ICC for intra-observer variability using investigator C, who perform analysis for all images twice with a 6 to 8 months interval. This analysis was performed with left ventricular fraction area change using transgastric left ventricular short axis view.
Interventions
PROCEDURESuction orogastric tube which is attached to TEE probe
Suction orogastric tube which is attached to TEE probe
Sponsors
Henry Ford Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult cardiac surgery or liver transplant surgery
Exclusion criteria
* TEE with significant wall motion abnormality or TEE contraindicated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning | TEE image sets were acquired after general anesthesia induction (before suction) and after 10minutes (after suction), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images in one day. | Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) | 6-8 months after initial images obtained during surgery | Investigator C assess all the image sets in one day again after 6-8 months to determine if there is intra-observer variability with the initial assessment of image quality, All investigators are blinded to which images are obtained before or after suction |
| Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer) | Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning) | The reproducibility of the LV FAC was assessed, assuming that better image quality would yield better LV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of tall TEE image sets (i.e. before and after suction) post oc. These image sets were combined, and assessment was done for each group (i.e. before and after suctioning) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TEE Image Before and After Suction Surgeries which need intraoperative TEE (i.e. cardiac surgery and orthotopic liver transplant) | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | TEE Image Before and After Suction | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 40 Participants | — |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 6.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 47 participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 33 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning
Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)
Time frame: TEE image sets were acquired after general anesthesia induction (before suction) and after 10minutes (after suction), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images in one day.
Population: Surgeries which need intraoperative TEE (cardiac or liver transplant surgery)
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| TEE Image Before and After Suction | Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning | Improved after suction | 79 image sets |
| TEE Image Before and After Suction | Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning | Same after suction | 62 image sets |
| TEE Image Before and After Suction | Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning | Worse after suction | 0 image sets |
Secondary
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer)
The reproducibility of the LV FAC was assessed, assuming that better image quality would yield better LV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of tall TEE image sets (i.e. before and after suction) post oc. These image sets were combined, and assessment was done for each group (i.e. before and after suctioning)
Time frame: Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning)
Population: Patients who need intraop TEE for cardiac surgery and liver transplant surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suction | Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer) | intraclass correlation coefficients of LV FAC before suction | 0.659 intraclass correlation coefficient |
| TEE Image Before and After Suction | Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer) | intraclass correlation coefficients of LV FAC after suction | 0.903 intraclass correlation coefficient |
Secondary
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer)
Investigator C assess all the image sets in one day again after 6-8 months to determine if there is intra-observer variability with the initial assessment of image quality, All investigators are blinded to which images are obtained before or after suction
Time frame: 6-8 months after initial images obtained during surgery
Population: Patients who need intraop TEE for cardiac surgery and liver transplant surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEE Image Before and After Suction | Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) | intraclass correlation coefficients of LV FAC before suction | 0.716 intraclass correlation coefficient |
| TEE Image Before and After Suction | Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) | intraclass correlation coefficients of LV FAC after suction | 0.935 intraclass correlation coefficient |